A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Scleroderma

In brief

This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020. The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using two different doses of BMS-986020.

Key facts

Study ID: NCT02588625
Run by: Bristol-Myers Squibb
People needed: 0
Starts: 2016-02-01
Expected to finish: 2019-10-01
Last updated by the study team: 2016-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of diffuse cutaneous systemic sclerosis for 60 months or less
Men and women ≥ 18 years of age
Ability to comply with birth control requirements
Certain immunosuppressive agents are permitted

You may not qualify if…

Limited cutaneous systemic sclerosis or sine scleroderma
Active ulcers on fingers
Pulmonary arterial hypertension
Any gastrointestinal surgery that may impact absorption of study drug

Where it is running

Local Institution — Scottsdale, Arizona, United States
Local Institution — Los Angeles, California, United States
Local Institution — Stanford, California, United States
Local Institution — Aurora, Colorado, United States
Local Institution — Washington D.C., District of Columbia, United States
Local Institution — Washington D.C., District of Columbia, United States
Local Institution — Chicago, Illinois, United States
Local Institution — Baltimore, Maryland, United States
Local Institution — Boston, Massachusetts, United States
Local Institution — Boston, Massachusetts, United States
Local Institution — Ann Arbor, Michigan, United States
Local Institution — New Brunswick, New Jersey, United States
Local Institution — Albany, New York, United States
Local Institution — New York, New York, United States
Local Institution — New York, New York, United States
Local Institution — Cleveland, Ohio, United States
Local Institution — Pittsburgh, Pennsylvania, United States
Local Institution — Charleston, South Carolina, United States
Local Institution — Houston, Texas, United States
Local Institution — Hamilton, Ontario, Canada
Local Institution — London, Ontario, Canada
Local Institution — Bydgoszcz, Poland
Local Institution — Lublin, Poland
Local Institution — Poznan, Poland
Local Institution — Szczecin, Poland

Full record on ClinicalTrials.gov

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